Medical Device Toxicologist II (605075)

Additional Location(s):USMNArden Hills

Diversity Innovation Caring Global Collaboration Winning Spirit High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and highperforming employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:
The Medical Device Toxicologist II at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. Additionally this position is responsible for the biological evaluation of medical device products in accordance with ISO 10993 in support of new product development and sustaining activities (e.g. manufacturing and engineering changes) as well as in support of regulatory submissions. Global Toxicology and Biocompatibility plays a critical role in medical device development ensuring patient safety while enabling early product development decisions product design direction product approvals and market launch for product commercialization.

Work Mode:
At Boston Scientific we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation Assistance:
Relocation assistance is not available for this position at this time.

Visa Sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology related information and data are accurate reliable and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements.
• Demonstrate a primary commitment to patient safety and product quality.
• Under direction and mentorship of senior staff completes biocompatibility evaluations and safety assessments as necessary to support business objectives.
• Provides input on the regulatory requirements related to medical device submissions on procedures techniques concepts and approaches used at divisional levels for biocompatibility and toxicology programs.
• May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials which may include issues related to materials of animal origin color additives exposure assessments of chemicals and other chemical toxicities as assigned.
• Communicates with internal customers on biocompatibility and toxicology issues supports problem solving and resolution related to related to biocompatibility assessments chemical characterization and toxicological risk assessments.
• Participates as assigned in training for functional groups of device development teams based on standards and regulatory requirements.
• Provides input on biocompatibility chemistry and toxicology testing related to new investigational and strategic device development programs.
  

Required qualifications:

• A BS / MS degree in Toxicology is preferred or closely related field (biology chemistry biochemistry biomedical engineering).
• Minimum of 23 years experience supporting medical devices.
• Knowledge of the biological evaluation of medical devices (ISO 109931) preferred. Working knowledge of risk assessment methodologies including the toxicological evaluation of medical device materials.
• Working knowledge of regulatory standards and global regulatory requirements with respect to medical device.
• Experience with running GLP and nonGLP studies.
• Excellent written and verbal communication skills.
• Results and detailoriented.
• Able to multitask while working against aggressive timelines.
• Comfortable in a dynamic environment and able to work independently as well as on teams.

Preferred Qualifications:

• A BS / MS degree in Toxicology is preferred

Requisition ID:605075

Minimum Salary:$72800

Maximum Salary: $138300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for nonexempt (hourly) nonsales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt nonsales roles may also include variable compensation i.e. annual bonus target and longterm incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre a natural problemsolver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you!

At Boston Scientific we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion equality and opportunity for all. By embracing the richness of our unique backgrounds and perspectives we create a better more rewarding place for our employees to work and reflect the patients customers and communities we serve.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy the Company will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identify gender expression veteran status age mental or physical disability genetic information or any other protected class.

Please be advised that certain US based positions including without limitation field sales and service positions that call on hospitals and/or health care centers require acceptable proof of COVID19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company you will be expected to meet the ongoing requirements for your roles including any new requirements should the Companys policies or protocols change with regard to COVID19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safetysensitive positions. This role is deemed safetysensitive and as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.